Chronic Effect of Fasting
ConditionOverweight and Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-59
SponsorFederal University of Minas Gerais
About this trial
The aim of the study is to determine if time-restricted feeding (TRF) is an effective dietary strategy to weight loss after 8 weeks intervention. TRF will be compared with an intervention without restriction in time for feeding. Both strategies will be with caloric restriction.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Females;
Aged between 18 and 59 years old;
Body mass index equal or greater 25 kg/m²;
Agree to sign the informed consent.
Disqualifiers
Any chronic health conditions (e.g. chronic renal failure, autoimmune, heart, and liver disease);
Thyroid diseases or medications for its treatment;
Medications known to affect total energy expenditure;
Use of steroids, immunosuppressants or non-steroidal anti-inflammatory drugs, weight-loss medications, oral hypoglycemic agents or insulin and any medications that influence metabolic and/or inflammatory parameters;
Trial design
Design model
Parallel
Treatments tested in this trial
Caloric restriction only
BehavioralParticipants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements), without restriction in time for feeding, for 8 weeks.
Caloric restriction plus TRF morning
BehavioralParticipants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements) and 8 hours for eating (from 12 p.m. to 8 p.m.) and 16 hours of fasting, for 8 weeks.
Caloric restriction plus TRF night
BehavioralParticipants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements) and 8 hours for eating (from 8 a.m. to 4 p.m.) and 16 hours of fasting, for 8 weeks.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Caloric restriction onlyActive comparator 1 intervention
Group B: Caloric restriction plus TRF morningExperimental treatment 1 intervention
Group C: Caloric restriction plus TRF nightExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in body weight
Body weight will be assessed by mechanical scale
Time frame
Baseline and weeks 2, 4 and 8Secondary outcomes
1
Change in body composition
Body composition will be assessed by electrical bioimpedance
Time frame
Baseline and weeks 2, 4 and 82
Change in resting energy expenditure
Resting energy expenditure will be assessed by indirect calorimetry
Time frame
Baseline and weeks 2, 4 and 83
Change in self-reported energy intake
Dietary energy intake will be assessed with 3-days food records
Time frame
Baseline and weeks 2, 4 and 84
Change in self-reported diet composition
Dietary macronutrient intake will be assessed with 3-days food records
Time frame
Baseline and weeks 2, 4 and 8Other outcomes
1
High-sensitivity C-reactive protein
Change will be assessed in blood sample
Time frame
Baseline and weeks 2, 4 and 82
Insulin
Change will be assessed in blood sample
Time frame
Baseline and weeks 2, 4 and 83
Leptin
Change will be assessed in blood sample
Time frame
Baseline and weeks 2, 4 and 84
Ghrelin
Change will be assessed in blood sample
Time frame
Baseline and weeks 2, 4 and 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov